Clinical Trials

Cancer Type: Breast

Hospitals offering this trial

1999-225
PILOT STUDY FOR ANALYSIS OF TUMOR GENE EXPRESSION BY DNA MICROARRAY ANALYSIS IN PATIENTS UNDERGOING BREAST CANCER SURGERY OR CORE BIOPSY SAMPLING

This study is for patients who are going to have surgery for breast cancer. The purpose of this study is to refine a technique that identifies differences in gene expression between breast tissue in different patients and to evaluate the ability of reflectance confocal microscopy to assess the adequacy and content of biopsy specimens immediately after they are collected. This information is important to better understand the diagnosis and treatment of breast cancer.

Patients who participate in this study will have several small pieces of tissue taken at the time of surgery for use in research tests.

Lombardi/MedStar Georgetown University Hospital

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Contact: Ann Gallagher
Email: ALG@georgetown.edu
Phone: 202-687-7606

2010-146
I-SPY 2 TRIAL: Investigation of Serial studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2.

This study is for women with newly diagnosed breast cancer who will receive chemotherapy prior to surgery (neoadjuvant therapy). There are 2 phases of this study: the screening phase and the treatment phase. The screening phase is to determine whether women are eligible to participate in the treatment phase. The purpose of the treatment phase is to try to determine how women with breast cancer will respond to standard chemotherapy and standard chemotherapy with investigational drugs on the basis of particular markers in the tumor tissue and blood. In addition to treatment all subjects on this study will be required to undergo 2 core biopsies of their tumor and have 3 breast MRIs for research purposes and have blood drawn for research studies. The standard chemotherapy in this trial is 12 weeks of paclitaxel followed by 4 cycles of doxorubicin and cyclophosphamide given once every 2 or 3 weeks. Subjects with HER2+ breast cancer will also receive trastuzumab during the 12 weeks of paclitaxel. Subjects will be randomized (like the flip of a coin) to either standard treatment or standard treatment plus an investigational (not yet approved by the FDA) drug. Which investigational drug one will receive will be based on when a subject enters the study and which drugs are being tested at that time.

Lombardi/MedStar Georgetown University Hospital

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Contact: Julie Castle
Email: bickmorj@georgetown.edu
Phone: 202-687-2209

 


2010-535
A Phase I/II Trial of TKI258 (Dovitinib) in Combination with an Aromatase Inhibitor in Patients with Metastatic Breast Cancer.

This study is for women with confirmed hormone receptor positive Her-2 negative advanced breast cancer with evidence of disease resistance to an aromatase inhibitor. The purpose of this study is to determine the effects (good and bad) of dovitinib in combination with anastrozole (1 mg daily), exemestane (25 mg daily) or letrozole (2.5 mg daily) in patients with hormone-receptor positive metastatic breast cancer whose cancer is getting worse while on initial treatment. This research is being done to find a safe dose of the combination of study drugs and to determine the potential side effects of the study drugs when given together. Depending on the side effects, not all subjects will receive the same dose of dovitinib. Potential patients may have received unlimited prior hormonal therapy, but must have had their disease worsen while receiving an aromatase inhibitor in the metastatic setting or within 6 months of completing adjuvant therapy with an aromatase inhibitor. Both Dovitinib and the aromatase inhibitors used in this study are pills that will be taken at home.

Lombardi/MedStar Georgetown University Hospital; Franklin Square Hospital Center; Washington Hospital Center

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Contact:
Email: Noviella@georgetown.edu, bickmorj@georgetown.edu
Phone: 202-784-0038, 202- 687-2209

 


2011-156
SCUSF 0806: Phase II placebo-controlled trial of lisinopril and Coreg CR to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin).

This study is for patients who have been diagnosed with breast cancer and are scheduled to start trastuzumab (Herceptin), which can cause problems with heart function. The purpose of this study is to compare the effects, good and/or bad, of an ACE inhibitor (lisinopril) or a beta-blocker (Coreg CR {carvedilol phosphate extended release]) on heart function during treatment with trastuzumab (Herceptin), a drug given as treatment for your breast cancer. Lisinopril and Coreg CR are used to treat high blood pressure, heart failure, and in heart attack patients. Study doctors want to find out which treatment (lisinopril or Coreg CR) is better at protecting heart function during treatment of breast cancer. The effect of the medicines will be compared to a placebo, which contains no active frug. All subjects will only get one of the study medicines (lisinopril, Coreg CR or placebo). The study medicine is given as a pill once a day.

Lombardi/MedStar Georgetown University Hospital; Washington Hospital Center

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Contact: Nellie Novielli or Julie Castle
Email: NOVIELLA@georgetown.edu, BICKMORJ@georgetown.edu
Phone: 202-784-3923 or 202-687-2209

 

2011-447
A Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer (RTOG 1005)

 

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2012-221

NSABP B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cylclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

 

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2013-025
Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias

The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors. The testosterone will be mixed with a little anastrozole to prevent any medication from turning into estrogen. The testosterone/placebo is a pellet that is placed just under your skin on the upper buttocks or lower abdomen. Our study team member will surgically place the pellet. In this study, you will receive either the testosterone or placebo. You will not receive both.

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2013-0278

SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients with HER2 Positive Breast Cancer and Reduced Left Ventricular Function.

To evaluate the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular ejection fraction (LVEF) when given concomitantly with cardiac treatment.

Lombardi/MedStar Georgetown University Hospital; Washington Hospital Center

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Contact: Antonella Novielli/ Julie Castle
Email: noviella@georgetown.edu, bickmorj@georgetown.edu
Phone: 202-784-3923/202-687-2209

2013-0364

SWOG S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating The Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer.

The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study, you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormonetreatment and everolimus is experimental in patients with breast cancer.

Lombardi/MedStar Georgetown University Hospital; Franklin Square Hospital Center; Union Memorial Hospital; Washington Hospital Center

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Contact: Nellie Novielli; Julie Castle
Email: noviella@georgetown.edu; bickmorj@georgetown.edu
Phone: 202-784-3923; 202-687-2209

 

2013-0381

Pilot Study to Evaluate Conditionally Reprogrammed Cells from Unresected Estrogen Receptor Positive Breast Tumors Treated with Endocrine Therapy Alone


You are being asked to participate in this study because the biopsies of your breast tumor may help investigators develop new tools for selecting the right therapy for each breast cancer patient. Breast cancer is an overgrowth of abnormal cells in the breast that can eventually spread to the other organs, if left untreated. Similarly to each person being different from another, also each breast cancer is different from one patient to another. Yet, currently most breast cancers are treated with the same combination of medications. Sometimes a medication that works for one patient, does not work for another due to the fact that her breast cancer is different. The breast cancer cells collected from the biopsies will be grown on a dish and drugs will be tested on the cells, instead of testing the drugs on patients

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2013-0618
A Randomized, Multicenter, Double -Blind Phase 3 Study Of PD-0332991 Plus Letrozole Vs Placebo Plus Letrozole In Postmenopausal Women Weith ER (+), HER2 (-) Breast Cancer who have not received any prio systemic anti-cancer treatment for advanced disease.

The purpose of this research study is to compare the effects of the study drug, PD-0332991 in combination with letrozole, with placebo in combination with letrozole to find out which is better for treating advanced breast cancer.

  • PD-0332991 is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country.
  • A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.
  • Letrozole is a drug that is approved for the treatment of advanced breast cancer that is sensitive to hormonal treatment. You do not have to participate in this study to receive letrozole. Letrozole is available outside of this research study by a doctor's prescription.

PD-0332991, letrozole and placebo are taken by mouth.

Subjects will be randomized into one of two treatment regimens.
1. PD-0332991 plus Letrozole OR
2. Placebo Plus Letrozole.

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2013-0962

A Pilot Study to Evaluate Conditionally Reprogrammed Cells from Triple Negative Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy


Breast cancer research led to improved treatments. However, not all breast cancers can be currently cured. Cancers that may seem very similar to each other can behave very differently. An example of such cancer is triple negative breast cancer, a subtype that is only sensitive to chemotherapy. Some triple negative breast cancers are cured with chemotherapy, while others are not sensitive to the drugs that we currently use. However, we do not know how to distinguish them from each other and women with this type of cancer receive the same type of treatments, which may or not be effective. Therefore, we need to understand how we can predict which tumors will do well with the available drugs and develop better drugs for those that do not.
This study aims to test a new promising technique that allows growing cancer cells from a patient in the laboratory. If the technique works well in breast cancer, these cells could then be studied and new treatments could be tested. The knowledge obtained this way could have a significant impact in the development of breast cancer treatments, particularly for tumors like triple negative breast cancer that currently have limited treatment options.

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2013-1173
ECOG E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer.

The standard treatment for metastatic breast cancer is the use of chemotherapy, anti-hormone pills, or other medication. When the cancer is no longer only in the breast and has spread to other areas of the body, surgery and/or radiation for the tumor in the breast cannot control the other areas of the cancer and are only used if the breast tumor is causing skin breakdown or pain, which happens only in some patients. For most people, the tumor in the breast is controlled with medicine and does not cause problems. We do not know if local treatment (surgery and/or radiation) used early in the course of treatment of the breast cancer will help patients with metastatic breast cancer live longer or not. The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor. In this study, you will get either surgery plus radiation for your breast, or continue with the best medical treatment advised by your doctor. If you receive the standard treatment but the medicine is no longer controlling the tumor in the breast, and your doctor feels you need surgery or radiation, you may receive this when you need it.

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2013-1226
A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients with Operable HER2-Po.

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This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combination with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenously (iv) every three weeks or Herceptin 6 mg/kg iv every three weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment is up to 1 year.


2013-1362
OSU 13117: A single arm, phase II study of single agent trametinib followed by trametinib in combination with GSK2141795 in patients with advanced triple negative breast cancer.

This study is for patients who have a partial or complete response to treatment with trametinib in advanced triple negative breast cancer (TNBC) patients. This is an open label, two-stage phase II study of single agent trametinib followed by trametinib in combination with GSK2141795 in patients with advanced TNBC.

Your body has proteins that are involved in a cancer's ability to grow and survive. Trametinib and GSK2141795 may prevent these proteins from causing cancer growth.

There are 2 parts to this study. In Part 1 of this study, you will receive trametinib. At a time in which trametinib is not working you will begin on Part 2 of the study. In Part 2 of this study, you will receive trametinib and GSK2141795.

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Pro-526
CALGB 40903: Phase II Study of Neoadjuvant Letrozole for Postmenopausal Women with Estrogen Receptor Positive Ductal Carcinoma In Situ (DCIS).

This study is for postmenopausal women who have ductal carcinoma in situ (DCIS), an early change in the breast that could become breast cancer in the future.

Standard treatment for DCIS includes surgery to remove the DCIS cells from the breast, or surgery followed by radiation therapy. The purpose of this study is to test whether neoadjuvant (neoadjuvant means given before surgery) treatment with the aromatase inhibitor (anti-hormonal medication) letrozole has an effect on the DCIS.

Mammograms are the standard method of detecting and measuring DCIS. The researchers conducting this study would also like to learn more about whether Magnetic Resonance Imaging (MRI) may be better for evaluating and measuring DCIS, compared to mammograms.

Subjects on this study will take letrozole as a pill once a day for up to 6 months and have an MRI for research purposes after 3 months and 6 months of treatment before surgery.

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Pro-465
NSABP B-47: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Traztuzumab in

This is a clinical trial, which is a type of research study. You are being asked to take part in this study because you have early stage breast cancer that has been removed by surgery. Your doctor has told you that chemotherapy and other therapy after surgery will lower the chance of your cancer returning. Your breast tumor has already been tested to find out if there are too many copies of the HER2 gene in the tumor cells or too much HER2 protein on the surface of the tumor cells. When there are too many copies of the HER2 gene or too much HER2 protein, the breast cancer is called "HER2-positive". Test results have shown that your breast cancer tumor is not HER2-positive, which means that your tumor cells have a low HER2 level. In this consent form, a low level of HER2 will be called "HER2-low". This study is only for women with HER2-low breast cancer.

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